CHICAGO, July 30, 2014 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc. (Nasdaq:DRTX) announced today that its Dutch subsidiary, Durata Therapeutics International B.V., has entered into a license and supply agreement with Angelini, an international group leader in the pharmaceutical and mass-market sectors, to commercialize dalbavancin in 36 countries, which include Italy, Spain, Poland, Portugal, many Eastern European countries, Russia, Turkey, and Commonwealth of Independent States.
Durata will receive an upfront payment from Angelini of $15 million and another $10 million upon European Medicines Agency (EMA) approval. The Company will also receive payments upon the achievement of certain countries' pricing approvals and sales milestones, as well as royalties on sales. Durata's Marketing Authorization Application (MAA) for dalbavancin is under review with the European Medicines Agency and anticipates a decision in 1H 2015.
Durata owns the worldwide rights for development and commercialization or partnering of dalbavancin. Durata is currently commercializing DALVANCE™ (dalbavancin) for injection in the U.S. and, if approved in the EU, may choose to directly commercialize in the remaining parts of Western Europe, including the United Kingdom, Germany, and France, with a targeted hospital salesforce and to use a variety of collaboration arrangements for commercialization in other markets.
"We are pleased to have entered into this agreement with Angelini, a well-respected pharmaceutical company with rich history and significant experience marketing hospital-based products. This partnership is aligned with our strategy to bring dalbavancin to the market for the millions of people who may benefit from an innovative treatment option for serious skin infections in today's evolving health care environment," said Paul R. Edick, Durata's Chief Executive Officer.
"Angelini is proud of partnering dalbavancin with Durata for treating patients affected by serious skin infections. The new approach will allow patients, healthcare professionals and hospitals to overcome the standard daily or twice-daily IV antibiotic infusions," said Gianluigi Frozzi, Angelini Pharmaceutical Division's Chief Executive Officer. "The agreement is part of the Angelini effort in the field of treatment of infectious diseases. Once approved in the EU, our experienced sales force and extensive network will bring dalbavancin to over 30 countries."
ABOUT DALVANCE™ (dalbavancin) for injection
DALVANCE is a second generation, semi-synthetic lipoglycopeptide, which consists of a lipophilic side-chain added to an enhanced glycopeptide backbone. DALVANCE is the first and only IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes. DALVANCE demonstrates bactericidal activity in vitro against a range of Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant, also known as MRSA, strains) and Streptococcus pyogenes, as well as certain other streptococcal species. In May 2014, Durata received FDA approval of DALVANCETM (dalbavancin) for injection for the treatment of ABSSSI in adults.
For important prescribing and safety information, please see www.dalvance.com.
ABOUT DURATA THERAPEUTICS, INC.
Durata Therapeutics is a pharmaceutical company focused on the development and commercialization of new therapeutics for patients with infectious diseases and acute illnesses. For more information about the company, visit www.duratatx.com.
DALVANCE is a trademark of Durata Therapeutics Holding C.V.
ABOUT ANGELINI
Angelini is a privately-held, mid-sized international manufacturer and marketer of pharmaceutical and healthcare products in the pharmaceutical and mass-market sectors. Founded in Italy in 1919, the group employs about 4,000 people. The pharmaceutical sector is the core business of the group, representing over 50% of the company's €1.4 billion 2013 revenue.
Angelini pharmaceutical products are available in over 60 countries through its branches and an extensive network of licensees and strategic agreements with local pharmaceutical companies.
At an international level, the company focuses mainly on pain relief, inflammation, CNS, antinfectives, gynaecology and has a strong position in the OTC market. The R&D department is currently focused on pain/inflammation, CNS and infectious diseases areas. In the latter, R&D is active with program in discovery, including private-public projects with New Chemical Entities, as well as clinical programs with already marketed products fully developed in Europe by Angelini.
Angelini also operates in Personal Care and Machinery sectors, in joint venture with Procter & Gamble, and in Perfumery and Winegrowing.
FORWARD-LOOKING STATEMENTS
Statements contained in this press release contain forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Forward-looking statements in this press release include statements about the timing of EMA's approval of dalbavancin, milestones and royalties. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the "Risk Factors" section of our most recent report on Form 10-K, which is on file with the SEC and is also available on our website. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.